Department of Medical Imaging, Xuzhou Central Hospital, 199 South Jiefang Road, Xuzhou, China.
Department of Interventional Radiology, Northern Jiangsu People's Hospital, Clinical Medical College of Yangzhou University, Yangzhou, China.
Abdom Radiol (NY). 2019 Aug;44(8):2900-2908. doi: 10.1007/s00261-019-02010-6.
To compare the clinical outcomes between unilateral and bilateral metal stenting for patients with malignant hilar biliary obstruction (MHO).
This is a single-center, open-label, prospective, randomized study. Between January 2016 and March 2018, patients with MHO who were treated by percutaneous unilateral or bilateral metal stenting were enrolled. The primary endpoint was stent dysfunction. The secondary endpoints included technical success, clinical success, adverse events, and death. The protocol is registered at ClinicalTrials.gov (identifier: NCT02649712).
A total of 72 patients were randomly grouped for the unilateral (n = 36) or bilateral (n = 36) stenting. The bilateral stenting was performed through the side-by-side technique. While technically, the rates of success of unilateral and bilateral stenting were 83.3% (30/36) in both the cases (P = 1.000), the clinical rates of success in unilateral and bilateral stenting were 90.0% (27/30) and 96.7% (29/30), respectively (P = 0.605). Based on the per-protocol analysis, stent dysfunction was found in 5 and 3 patients in unilateral and bilateral groups, respectively (16.7% vs. 10.0%, P = 0.704). No predictor was observed to influence stent dysfunction. The median cumulative survival in the unilateral group was 122 days and in the bilateral group was 125 days (P = 0.844). We also observed higher levels of post-operative total bilirubin and pre-operative alanine aminotransferase, and the absence of post-operative anticancer treatment as predictors of worse survival.
When compared, the bilateral and unilateral stentings provide a similar clinical effectiveness in patients with MHO.
比较单侧和双侧金属支架置入治疗恶性肝门胆管梗阻（MHO）患者的临床疗效。
这是一项单中心、开放标签、前瞻性、随机研究。2016 年 1 月至 2018 年 3 月，纳入接受经皮单侧或双侧金属支架置入治疗的 MHO 患者。主要终点是支架功能障碍。次要终点包括技术成功率、临床成功率、不良事件和死亡率。该方案在 ClinicalTrials.gov 注册（标识符：NCT02649712）。
共 72 例患者随机分为单侧（n=36）或双侧（n=36）支架组。双侧支架采用并排技术置入。虽然在技术上，单侧和双侧支架置入的成功率分别为 83.3%（30/36）和 100%（36/36）（P=1.000），但单侧和双侧支架置入的临床成功率分别为 90.0%（27/30）和 96.7%（29/30）（P=0.605）。根据意向性治疗分析，单侧和双侧支架组分别有 5 例和 3 例患者发生支架功能障碍（16.7%比 10.0%，P=0.704）。未观察到预测支架功能障碍的因素。单侧支架组的中位累积生存率为 122 天，双侧支架组为 125 天（P=0.844）。我们还观察到术后总胆红素水平升高和术前丙氨酸氨基转移酶水平升高，以及术后无抗癌治疗是生存较差的预测因素。
与单侧支架置入相比，双侧支架置入在治疗 MHO 患者方面具有相似的临床疗效。
